Table of Contents
PPT Slide
Overview
Introduction to Labeling
Introduction to Labeling (continued)
Labeling 101
Labeling: Focal Point for Negotiations
Opportunities for New Data
Postmarketing Safety Information Spontaneous Reports
“Serious” Adverse Events (at any dose)
“Unexpected”
Limitations of Case Reports
When are case reports helpful?
Existing Pregnancy Section of Label
“Pregnancy Categories”
Lack of Data
Experience and Feedback
Use only in pregnancy when the benefit outweighs the risk!
Changes are coming….
ICH E2C
ICH E2C (continued)
Risk Communication
Scientific & Regulatory Decisions
Special Challenges: Pregnancy and Perinatal Exposures
Conclusions
Conclusions (continued)
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